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Psychotropic Drug Experiences Collectively Challenge Standard Mental Health Practices

Psychotropic Drug Experiences Collectively Challenge Standard Mental Health Practices. Shannon Hughes, MSW, Ph.D. Assistant Professor Colorado State University, School of Social Work Presented at National Association for Rights Protection and Advocacy August 28, 2016.

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Psychotropic Drug Experiences Collectively Challenge Standard Mental Health Practices

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  1. Psychotropic Drug Experiences Collectively Challenge Standard Mental Health Practices Shannon Hughes, MSW, Ph.D. Assistant Professor Colorado State University, School of Social Work Presented at National Association for Rights Protection and Advocacy August 28, 2016

  2. Pharmaceutical Industry Reporting

  3. Strattera / atomoxetine

  4. Little Attention is Given to Harms Assessment

  5. Poor Assessment of AEs in Published Clinical Trial Reports

  6. Few AEs are Specifically Assessed or Monitored

  7. Unclear How Drugs’ Effects are Interpreted and Labeled by Investigators

  8. Under-reporting of Serious Adverse Events (SAEs)

  9. Under-reporting of Serious Psychiatric Adverse Events

  10. User Reporting on the Internet

  11. User-reported AEs

  12. User Reporting vsClinical Trial Reporting

  13. AEs are Experienced Subjectively Along a Continuum of Burden Horrible Terrifying Unbearable Intolerable I want off this drug Worst drug ever I cannot live like this n=216 Constant Very A lot Major Extreme A real problem Not sure it’s worth it n=188 Some A little Minimal Manageable It’s worth it n=128 Severe Moderate Mild

  14. Drug Information – Manufacturer Reporting Conclusions: Lurasidone 80 mg and 160 mg doses administered once-daily in the evening, were safe and effective treatments for subjects with acute schizophrenia, with increased response rates observed at the higher dose. Dose-related adverse effects were limited, and both doses were generally well-tolerated. [Loebel, et al., 2013]

  15. Drug Information – Manufacturer Reporting

  16. Sedating Effects of Seroquel: • Sleepiness • Cognitive slowing, dulling Activating Effects of Latuda: • Increased energy • Increased anxiety, agitation • Restlessness, akathisia “A significant ‘spacy’ feeling...Of course, that’s not a problem if I go to bed within 20 minutes of taking it. Should I wake up in the middle of the night, I’m disoriented and have walked into walls, etc…On the positive side,…Seroquel dramatically CALMS me down both mentally and physically.” “The first night I took it I felt mentally and physically like I was being purged of all my anxiety and bad feelings. Very uncomfortable but after about an hour I slept peacefully.” Mild “I felt like bugs were crawling all over my bones. I couldn’t sit still. I would go into these intense mini-manias every night where I would be agitated, crying hysterically, walking in circles. I felt like tearing my hair out and screaming and running down the street all at the same time….Ugh it was just awful!” “shredded my memory…as if my memory was a series of overlapping gauzy sheets with subtle paintings on them, and Seroquel just ripped huge pieces at random out of one sheet after another. I could never even remember what day of the week it was” Severe

  17. Drug Information – User Reporting

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